Senior Exec Leaves Novartis After Major Quality Problems

Senior Exec Leaves Novartis After Major Quality Problems

March 1st, 2012 // 1:44 pm @

Source: Pharmalot

Exactly one year after joining Novartis to run its over-the-counter division and less than two months after joining the executive committee, Naomi Kelman has resigned from the drugmaker and her replacement at the OTC unit is Brian McNamara, according to a statement.

Her departure comes on the heels of an embarrassing and costly episode at a key OTC plant in Lincoln, Nebraska, where Novartis recently suspended production following multiple FDA inspections that found glaring manufacturing and quality control lapses. In particular, there were mix-ups in which one product was found in bottles meant for another. OTC and Animal Health meds have since been recalled, and hundreds of millions of dollars in lost sales are now expected.

“Naomi Kelman came to our OTC business to leverage her strengths in innovation and marketing. As the conditions of the business changed, it became clear that a strong effort in manufacturing and supply chain would be essential to growing the business. Naomi and I have, therefore, been discussing for some time that this time commitment would limit her focus on her areas of interest. Naomi has, therefore, decided to seek other opportunities outside our company,” Novartis ceo Joe Jiminez wrote in a memo to employees (read here).

Why is a strong effort in manufacturing and supply chain so essential? Consider the problems cited by the FDA. The drugmaker had failed to open inspections into consumer complaints of foreign products found in its solid-dosage form meds and also failed to investigate dozens complaints of foreign tablets in its meds going as far back as 2009.

There were numerous instances in which Novartis failed to file so-called field alerts within three days of being notified of any problems. And quality assurance was slow to review complaints. Last year, the Novartis received 223 critical complaints and the FDA determined that none of them were reviewed properly (read more here and here).

Making matters worse, Novartis insisted the problems were beyond its control even though the FDA noted the drugmaker failed to properly investigate many of the reports and could not present any evidence to justify its conclusion. However, the problem has gotten so severe that prescription painkillers made for Endo Pharmaceuticals at the same facility wound up in some bottles for other meds, although it remains unclear if these were OTC or prescription.

Before joining Novartis, Kelman was president of LifeScan North America, which is part Johnson & Johnson, where she had worked since in 2000 and also held several managerial roles in the Consumer Health, Medical Device and Diagnostic businesses (see this). As for McNamara, he joined the Novartis OTC unit in 2004 after spending 20 years at Procter & Gamble.

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